CN108348197B

CN108348197B - Kit for determining analyte concentration

Info

Publication number: CN108348197B
Application number: CN201680063914.XA
Authority: CN
Inventors: S-M.弗雷; O.库贝; W.黑克; H.瓦尔特
Original assignee: F Hoffmann La Roche AG
Current assignee: F Hoffmann La Roche AG
Priority date: 2015-09-02
Filing date: 2016-09-01
Publication date: 2021-08-13
Anticipated expiration: 2036-09-01
Also published as: EP3138489A1; SI3138489T1; PL3138489T3; US10806384B2; ES2812607T3; CN108348197A; US20190374138A1; WO2017037191A1; HK1258925A1; RU2707819C2; DK3138489T3; RU2018111521A3; CA2997037A1; CA2997037C; WO2017037191A8; EP3138489B1; RU2018111521A

Abstract

A kit (110) for determining a concentration of at least one analyte in a body fluid of a user is disclosed, the kit (110) comprising: a) a sensor module (112) comprising: i. at least one sensor element (114) adapted to determine a concentration of an analyte, wherein the sensor element (114) is at least partially implantable in a body tissue (174) of a user; at least one control device (116) connected to the sensor element (114), wherein the control device (116) comprises at least one data collection device (120) adapted to collect measurement data acquired by using the sensor element (114), wherein the control device (116) further comprises at least one wireless near field communication device (122) adapted to transmit the measurement data, wherein the sensor module (112) comprises a sensor module mechanical interface (126); b) at least one data reader module (132) adapted to receive measurement data transmitted by the sensor module (112) via wireless near field communication, wherein the data reader module (132) comprises at least one data storage device (150) and is adapted to store the measurement data; c) at least one data transmission module (134) adapted to receive measurement data transmitted by the sensor module (112) via wireless near-field communication, wherein the data transmission module (134) comprises at least one wireless far-field communication device (152), wherein the wireless far-field communication device (152) is adapted to transmit at least a portion of the measurement data to an external device (156) via wireless far-field communication. Each of the data reader module (132) and the data transmission module (134) comprises a mechanical interface (138, 140) adapted to reversibly engage the sensor module mechanical interface (126), thereby alternatively generating a fixed spatial relationship between the sensor module (112) and the data reader module (132) or the sensor module (112) and the data transmission module (134).

Description

Kit for determining analyte concentration

Technical Field

The present invention relates to a kit for determining the concentration of at least one analyte in a body fluid of a user. The invention further relates to a method for determining the concentration of at least one analyte in a body fluid of a user, the method comprising the use of a kit according to the invention. The kit and method according to the present invention are primarily intended for long term monitoring of analyte concentrations in body fluids, such as blood glucose levels or the concentration of one or more other types of analytes in body fluids. The invention can be applied both in the field of home care and in the field of professional care, such as in hospitals.

Background

Monitoring certain bodily functions, and more particularly monitoring one or more concentrations of certain analytes, plays an important role in the prevention and treatment of various diseases. Without restricting further possible applications, the invention will be described in the following text with reference to blood glucose monitoring. However, the invention may also, additionally or alternatively, be applied to other types of analytes.

In addition to so-called field measurements, in which a sample of a body fluid is taken from a user in a targeted manner and is examined with respect to the analyte concentration, continuous measurement results are increasingly being established. Thus, in recent times, continuous measurement of glucose in interstitial tissue (also referred to as continuous monitoring CM), for example, has been established as another important method for managing, monitoring and controlling the state of diabetes.

In this process, an active sensor region is applied directly to the measurement site (which is usually arranged in the interstitial tissue) and, for example, converts glucose into an electrical charge by using an enzyme (e.g. glucose oxidase GOD), which electrical charge is related to the glucose concentration and can be used as a measurement variable. Examples of such transcutaneous measurement systems are described in US6,360,888B 1 or in US 2008/0242962 a 1.

Thus, current continuous monitoring systems are typically transcutaneous systems. This means that the actual sensor or at least the measuring part of the sensor is arranged under the skin of the user. However, it is common to have the evaluation and control part of the system (also called patch) located outside the body of the user, that is to say outside the human or animal body. In this process, the sensors are generally applied using an insertion instrument, which is also described in an exemplary manner in US6,360,888B 1. Other types of insertion instruments are also known.

WO 2008/124597 a1 discloses an analyte sensing device having one or more sensing electrodes. The analyte sensing device includes a body configured to reside on the skin of an individual when in use, the body having one or more electrical components. The analyte sensing device further includes an analyte sensing electrode extending substantially perpendicularly from the body and electrically coupled to the body. The analyte sensing electrode is configured for insertion into the skin of an individual.

Transcutaneous sensor systems often represent a number of technical challenges. Therefore, a first challenge lies in the fact that the lifetime of the sensor is limited. The sensor is typically worn for about a week. After this, effects such as the enzyme being used up and/or occlusion in the body generally reduce the sensitivity of the sensor, or the sensor is expected to fail. Increasing the duration of wear is one area of current research. However, this means that the sensor and optionally a component directly connected to the sensor (such as an insertion needle) are often designed as replaceable components. Thus, the sensor and optionally further exchangeable components usually constitute a so-called disposable. In contrast, in many cases, the evaluation and control portion of the system is reused. Therefore, the evaluation and control section is often embodied so-called reusable.

However, separation between disposable and reusable articles often implies additional technical challenges. Thus, an important challenge resides in the fact that the sensitive interface between the disposable part and the reusable part is susceptible to contamination, which may lead to a deterioration of the quality of the electrical measurement results. Furthermore, electrochemical systems are generally based on potentiostatic measurement principles and may generally only sustain very small currents, so electrode degradation may occur at higher currents. The degradation of the measurement signal may occur gradually over a long period of time and can only be detected electronically with great technical effort. These technical challenges are increased by the fact that the reusable portion is typically handled by the end user or patient rather than by trained medical staff.

US 2011/0152644 a1 discloses a protective container for holding a reusable control part of a transcutaneous sensor system for detecting at least one analyte in a body fluid. The control portion includes at least one coupling having at least one sensor coupling for connection to at least one transcutaneous sensor. The protective container has at least one container housing. The control portion may be stored in the container housing. The container housing is adapted to shield the control portion from environmental influences. The container housing also has at least one connector which can be connected to the coupling piece and seals it in a media-tight manner.

Another challenge of continuous monitoring systems resides in the fact that these systems require constant efforts to keep the volume of the sensor system, or at least parts of the sensor system, worn on the body of the user low in order to increase the comfort of wear. Therefore, the functionality of the sensor system must typically be kept low in order to avoid a large number of components (such as a display or a user interface). However, this reduction in functionality often leads to the fact that remote resources (such as for data evaluation and/or communication with the user) must be used. However, in this case, the one-way or two-way exchange of data and information between the sensor and the remote device becomes a problem. Several systems for managing this communication are known in the art.

WO 2012/068393 a1 discloses an analyte monitoring system comprising a housing on a body, an analyte sensor coupled to the housing, an electrical output interface disposed on an exterior surface of the housing, and a movable adapter coupled to the housing. The removable adapter serves as a data conduit between the analyte sensor and the remote device.

US 2010/0324392 a1 discloses a sensor comprising a body having a proximal section, a distal section longitudinally aligned with the proximal section, and an intermediate section. The intermediate section is transversely displaced from at least the distal member and defines a gap between the transversely displaced intermediate section and a portion of the distal section.

WO 2012/007437 a1 discloses a medical device for performing at least one medical function. The medical device comprises at least one element which can be at least partially inserted into a body tissue of a user. The medical device further comprises a housing with functional components that can be placed on the skin of a user.

WO 2011/154372 a1 discloses a medical device for detecting at least one analyte in a body fluid. The medical device comprises at least one implantable functional element, such as a sensor element, and at least one controller having at least one electronic component. The functional element may be connected to a controller. The controller includes a housing having at least one metal shell. The controller includes at least one wireless communication device. The metal housing includes at least one slot structure. The communication device is designed to communicate with at least one external device, such as a data manager, by means of a slot structure.

WO 03/005891 a1 discloses a method of controlling data information between two portable medical devices. Each device has means for one or more of: storing, transmitting, receiving, processing, and displaying data information. The two devices have multiple locations associated with each other during normal use. Data information relating to an operation performed by the device is exchanged via short-range communication when the devices are mutually positioned in one of a number of mutually associated positions.

US 8,280,476B 2 discloses a glucose monitor having a plurality of tissue perforating elements. Each tissue perforating element has a distal opening, a proximal opening, and an interior space extending between the openings. Further, a sensing region is provided in the fluid in communication with the proximal opening of the tissue perforating element. A sensing fluid is provided that extends from the sensing region to substantially the entire interior space of the tissue perforating element. Further, a glucose sensor is provided and adapted to detect a concentration of glucose in the sensing fluid within the sensing region.

EP 1611838B 1 discloses an analyte monitoring system comprising a sensor implantable in tissue for continuously monitoring the concentration of an analyte. The sensor includes a signal transmitter configured to transmit a first wireless signal. The analyte monitoring system further includes a handheld unit configured to receive the first wireless signal directly from the sensor and configured to measure the analyte concentration in a transitory manner using the disposable glucose test strip. The analyte monitoring system further includes a signal relay configured to directly receive the first wireless signal from the sensor and transmit a second wireless signal. The second wireless signal has a transmission range greater than a transmission range of the first wireless signal. The analyte monitoring system further includes at least one signal receiver configured to receive a second wireless signal.

WO 2008/083379 a1 discloses a device, system and method for delivering a device (such as a sensor or a fluid transport structure sensor combination) into e.g. mammalian skin and receiving, analyzing and displaying signals from the device such as a sensor. The system comprises: a reusable sensor assembly comprising a transmitter, a microcontroller, and a housing plus a disposable sensor assembly comprising a housing having a distal end for receiving a biosensor, both a sensor insertion guide structure; and a transmission device for communicating signals received from the sensor to the reusable sensor assembly for transmission to an external electronic monitoring unit.

EP 1850226 a1 discloses a device and a method for administering and managing a base unit for a handheld medical device. The base unit communicates with the handheld medical device. The base unit is configured to provide an electrical connection to a power source for charging a battery of the handheld medical device. The base unit is further configured to perform an update to the operation of the base unit, wherein the update is initiated by the base unit upon receiving a data stream from the handheld medical device, the data stream having information indicating that the update is contained in the data stream.

US 2005/0199494 a1 discloses an analyte sensor system. The analyte sensor system includes a sensor, a second control unit, and a display unit. The sensor control unit is adapted to accommodate a portion of the electrochemical sensor and comprises a transmitter for transmitting data obtained by using the sensor to the display unit.

US 2009/0240128 a1 discloses a system for continuous measurement of an analyte in a host. The system includes a continuous analyte sensor configured to continuously measure a concentration of an analyte in a host, and further includes a sensor electronics module physically connected to the continuous analyte sensor during use of the sensor. The sensor electronics module is configured to wirelessly communicate disposable sensor information directly to a plurality of different types of display devices.

Despite the advances made in the above-mentioned concepts, significant technical problems and challenges remain. Thus, in one aspect, the bulk of the body base remains a problem, as the comfort of wearing the body base in daily life must increase, particularly with the increased lifetime of the actual sensor. On the other hand, the functionality of the sensor system has to be increased, in particular with regard to data management and evaluation, warning functions and interaction with other medical devices such as insulin pumps. In particular, typical communication components that allow for the communication of data and/or commands are rather bulky. Further, the flexibility of potential use of the system must be increased. Still, the requirements of increased wearing comfort on the one hand and increased functionality and flexibility on the other hand are conflicting requirements and, therefore, present an increasing challenge to the system design of continuous monitoring systems.

The problem to be solved.

It is therefore an object of the present invention to provide a concept for determining the concentration of at least one analyte in a body fluid of a user, which avoids the above mentioned problems of known systems and devices and which faces the conflicting requirements of low volume and increased functionality.

Disclosure of Invention

This problem is solved by a kit and a method having the features of the independent claims. Preferred embodiments that may be realized in isolation or in any reasonable combination are set forth in the dependent claims.

As used in the following, the terms "having," "including," or "containing," or any grammatical variations thereof, are used in a non-exclusive manner. Thus, these terms may refer to both the case where there are no other features in the entities described in this context than those set forth by these terms and the case where there are one or more other features. As one example, the expressions "a has B", "a includes B", and "a includes B" may refer to both the case where no other element is present in a other than B (i.e., the case where a consists only and exclusively of B) and the case where one or more other elements are present in entity a other than B (such as elements C, elements C and D, or even other elements).

Further, as used in the following, the terms "preferably," "more preferably," "particularly," "more particularly," "specifically," "more specifically," or similar terms are used in connection with optional features without restricting the possibilities of alternatives. The features presented by these claims are therefore optional features and are not intended to restrict the scope of the claims in any way. As the skilled person will appreciate, the invention may be carried out by using alternative features. Similarly, features presented by "in embodiments of the invention" or similar expressions are intended to be optional features without any restriction as to the scope of the invention, without any restriction as to alternative embodiments of the invention, and without any restriction as to the possibility of combining features presented in this way with other optional or non-optional features of the invention.

In a first aspect of the invention, a kit for determining a concentration of at least one analyte in a body fluid of a user is disclosed.

As used herein, a "kit" is an assembly of components, where each component can function and can be operated independently of each other, where the components of the kit can interact to perform common functions. Thus, the kit may comprise a plurality of components, wherein each component may be operated independently of the other components and each component may independently perform at least one function, wherein further all components or a group of components comprising at least two of the components may be combined, such as by physically connecting the components, so as to perform a common function implying a function from the connected components.

As further used herein, the term "determining the concentration" relates to a process of generating at least one representative result or a plurality of representative results indicative of the concentration of the analyte in the body fluid.

As further used herein, the term "analyte" may refer to any element, component, or compound that may be present in a bodily fluid and a concentration that may be of interest to a user. Preferably, the analyte may be or may include any chemical substance or chemical compound (such as at least one metabolite) that may participate in the metabolism of the user. As an example, the at least one analyte may be selected from the group consisting of glucose, cholesterol, triglycerides, lactic acid. However, additionally or alternatively, other types of analytes may be used and/or any combination of analytes may be determined.

In general, any type of body fluid may be used. Preferably, the body fluid is a body fluid present in a body tissue of the user, such as in interstitial tissue. Thus, as an example, the body fluid may be selected from the group consisting of blood and interstitial fluid. However, additionally or alternatively, one or more other types of bodily fluids may be used. The body fluid may typically be contained in body tissue. Thus, in general, it is preferred that the concentration of the at least one analyte in the body fluid of the user can be determined in vivo.

As generally used in the present invention, the term "user" may refer to a human or animal, independent of the fact that the human or animal may be in a healthy condition or may be suffering from one or more diseases, respectively. As one example, the user may be a human or animal with diabetes. However, the invention may additionally or alternatively be applied to other types of users.

The kit includes the following components. As outlined above, the components may be operated independently of each other, i.e. each of the components may have at least one state in which the respective component is not mechanically connected to any other component. Additionally, as will be outlined in more detail below, the components of the kit have at least one state in which they are mechanically connected to at least one other component, thereby mechanically interacting with the component. Further, each of the components of the kit may have unique functions, such as measurement functions, data storage functions, and data transmission functions, that may be employed independently of the presence of the other components. Further, in the connected state, an interaction function may occur, which will be outlined in further detail below.

First, the kit includes at least one sensor module. The sensor module comprises at least one sensor element adapted to determine a concentration of an analyte, wherein the sensor element is at least partially implantable in a body tissue of a user. The sensor module further comprises at least one control device connected to the sensor elements, wherein the control device comprises at least one data collection device adapted to collect measurement data acquired by using the sensor elements. The control device further comprises at least one wireless near field communication device adapted to transmit measurement data.

As used herein, the term "sensor module" generally refers to a unit that can be handled as one entity, comprising at least one sensor element (preferably exactly one sensor element) and at least one control device (preferably exactly one control device).

As further used herein, the term "sensor element" generally refers to any element adapted to determine the concentration of an analyte. Thus, as will be outlined in further detail below, the at least one sensor element preferably comprises at least one sensor material, wherein the sensor material is adapted to perform at least one detectable reaction in the presence of an analyte. The sensor material may preferably be a sensor material selected from the group consisting of: an optical sensor material, wherein the optical sensor material is adapted to perform at least one optically detectable detection reaction in the presence of an analyte; an electrochemical sensor material, wherein the electrochemical sensor material is adapted to perform at least one electrically detectable detection reaction, such as an electrically detectable redox reaction, in the presence of an analyte.

The sensor element may preferably comprise at least one flexible substrate, such as a flexible substrate having an elongated shape, wherein the flexible substrate may extend into the body tissue of the user. In particular in case the at least one sensor element is an electrochemical sensor element, the sensor element preferably has two or more electrodes (such as at least one working electrode) and at least one further electrode (such as at least one counter electrode and/or at least one reference electrode) applied to the substrate. For potential examples of sensor elements, reference may be made to the prior art documents listed above, such as to a continuous transcutaneous measurement system as described in US6,360,888B 1 or in US 2008/0242962 a 1. Additionally or alternatively, other types of sensor elements may be used.

As further used herein, the term "at least partially implantable in the body tissue of the user" refers to the fact that the sensor element is adapted to have a suitable size to be inserted into the body tissue of the user (such as into subcutaneous tissue) and further that the sensor element is biocompatible so as to remain in the body tissue for an extended period of time (such as for days or even weeks or even months). Thus, as an example, the sensor element, or at least the implantable part of the sensor element, may have a biocompatible coating (such as at least one semipermeable membrane) which prevents migration of the sensor material into the body tissue and which is still permeable to the at least one analyte. Thus, as outlined above, the sensor element may comprise at least one flexible substrate, wherein two or more electrodes are provided on the substrate, wherein at least one of the electrodes is coated with a semipermeable membrane. Thus, the electrodes may each comprise electrically conductive electrode pads, wherein at least one of the electrode pads is coated with a sensor material acting as a working electrode. Two or more contact leads may be used to connect the conductive electrode pads.

The term "implanted" refers to the fact that the sensor element may be fully or partially inserted into the body tissue. Thus, in the following, the terms "implanted" and "inserted" will be used as synonyms. Generally, the sensor element may penetrate completely or partially through the skin of the user during implantation and/or during use of the sensor element. Thus, the sensor element may preferably be embodied as a transcutaneous sensor element.

As used herein, the term "control device" generally refers to any element adapted to acquire measurement data by using a data collection device. The control device may preferably be present on a skin surface of the user, wherein the sensor element preferably extends from the control device into the body tissue of the user. The control device may preferably have a closed housing, as will be outlined in further detail below. The data collection device may preferably have at least one electronic component connected to the sensor element, preferably electrically connected to the sensor element. As will be outlined in further detail below, the connection may be a permanent connection or a releasable and/or revocable connection.

Preferably, in particular in case the sensor element is an electrochemical sensor element, the data collection device may comprise at least one potentiostat, such as at least one potentiostat. In general, the data collection device may comprise at least one amplifier having a high input resistance, such as an input resistance of at least 1M Ω, preferably at least 100M Ω or even at least 1G Ω, such as 10G Ω. In general, reference may be made to electronic measurement arrangements as disclosed in US6,360,888B 1 or in US 2008/0242962 a1 for potential embodiments of the control device and the data collection device. However, as will be outlined in further detail below, the at least one control device is preferably a single control device which is not subdivided into reusable and disposable parts. Apart from this fact, the measurement settings as disclosed in these documents may be passed on to the present invention. Other embodiments are possible.

As further used within the present invention, the term "measurement device" refers to any data indicative of an analyte concentration obtained by using a sensor element. The measurement data may specifically include a plurality of measurements taken at subsequent points in time, such as over a period of hours, days, weeks, or even months. The measurement data may preferably be acquired in analog or digital electronic format. The measurement data may be further processed or pre-processed within the control device, such as by applying at least one evaluation or pre-evaluation algorithm to the measurement data. Thus, as an example, at least one algorithm may be applied to the measurement data, wherein the at least one algorithm transforms primary measurement data acquired by using the sensor element into secondary measurement data indicative of the concentration of the analyte in the bodily fluid, such as by applying a known or predetermined relationship between the primary measurement data and the analyte concentration to the primary measurement data, thereby generating the secondary measurement data. Here and in the following, there will be no difference between the primary measurement data (i.e. the measurement data directly acquired by using the sensor elements) and the secondary measurement data (which is generated by applying one or more evaluation or pre-evaluation algorithms to the primary measurement data).

As used herein, the term "near field communication" (abbreviated with NFC) generally refers to the wireless transfer of data over short distances of up to 10cm, typically with low data transfer rates, such as data transfer rates of no more than 424 kBit/s. As an example, near field communication may comply with a passive standard, i.e. a standard in which one of the communication partners is a passive component (which only answers communication requests received from another partner), such as the standards defined in ISO 14443 and/or ISO 15693. Thus, preferably, the near field communication may be an RFID communication, wherein preferably the wireless near field communication device of the control device is a passive element of the RFID communication. Additionally or alternatively, other types of near field communication may be used, such as near field communication in which the two partners of the communication are active partners (i.e., partners that can both send and receive communication requests).

The near field communication device may preferably comprise at least one communication component adapted to perform near field communication. Thus, as an example, the near field communication device may comprise at least one antenna. As one example, the near field communication device may comprise at least one RFID antenna, such as at least one RFID coil.

The transmission of measurement data using the wireless near field communication device may occur to one or more other elements, such as one or more other elements of the kit, as will be outlined in further detail below. Thus, the communication of the measurement data by using near field communication may take place with one or more of the data reader module, the data transmission module, the optional alarm module and the portable data management device, which will be explained in further detail below.

The sensor module further includes a sensor module mechanical interface. As used herein, the term "sensor module mechanical interface" generally refers to any element or combination of elements of a sensor module that is adapted to interact with at least one mechanical interface of a second element in order to generate a mechanical connection between the sensor module and the other element. As will be outlined in further detail below, the further element is preferably selected from the group consisting of a data reader module, a data transmission module, an optional alarm module and an optional portable data management device. In general, the sensor module mechanical interface may include any type of element or combination of elements that may be used to couple to other elements, such as one or more elements selected from the group consisting of protrusions, edges, hooks, recesses, grooves. Other types of connecting elements may additionally or alternatively be used.

The kit further comprises at least one data reader module adapted to receive measurement data transmitted by the sensor module via wireless near field communication. The data reader module includes at least one data storage device and is adapted to store measurement data.

As used herein, the term "data reader module" generally refers to a unit that can operate as a single element and is adapted to store measurement data. The data reader module may comprise at least one near field communication device for the purpose of receiving measurement data transmitted by the sensor module via wireless near field communication. Thus, as an example, a near field communication device according to one or more of the above mentioned standards may be used. As an example, the near field communication device of the data reader module may be an active device, while the wireless near field communication device of the control device of the sensor module may be a passive communication device. However, other options are possible, such as active communication devices in both components. The near field communication device of the data reader module may preferably comprise at least one antenna, such as at least one RFID antenna.

The data storage device may be any storage device adapted to store measurement data. Volatile and/or nonvolatile data storage devices may be used. As one example, a memory device (also referred to as a memory device or memory element) may include one or more memory chips and/or other types of memory devices, where both volatile and non-volatile memory devices may be employed.

The kit further comprises at least one data transmission module adapted to receive measurement data transmitted by the sensor module via wireless near field communication. The data transmission module comprises at least one wireless far-field communication device, wherein the wireless far-field communication device is adapted to transmit at least a part of the measurement data to an external device via wireless far-field communication.

As used herein, the term "data transmission module" generally refers to any unit that can be processed as a single element adapted to receive measurement data from a sensor module via wireless near-field communication and to transmit at least a portion of the measurement data to an external device via wireless far-field communication. Thus, the data transmission module may comprise at least one wireless near-field communication device adapted to communicate with the wireless near-field communication device of the control device of the sensor module. As an example, the near field communication device may be an active near field communication device, and the near field communication device of the control device of the sensor module may be a passive communication device. However, other options are possible, such as an active communication device in both elements.

As used herein, the term "wireless far-field communication" generally refers to wireless communication adapted to transmit data over long distances, such as distances of more than 10 cm. As an example, the wireless far-field communication may be any long-range communication using electromagnetic waves in the radio frequency range, i.e. may be a radio communication. Thus, as an example, the wireless far-field communication device of the data transmission module may comprise at least one radio module with at least one radio antenna for transmitting the measurement data to at least one external device via radio transmission.

As used herein, the term "external device" may be any device independent of the data transmission module and the sensor module adapted to receive measurement data via wireless far-field communication. The at least one external device may be part of the kit or may be independent of the kit. As one example, the at least one external device may be a portable device, such as a handheld computer and/or a smartphone, having the capability to communicate via wireless near field communication. Other examples are possible.

Each of the data reader module and the data transmission module includes a mechanical interface adapted to reversibly engage the sensor module mechanical interface. Thus, the data reader module may comprise a data reader module mechanical interface and the data transmission module may comprise a data transmission module mechanical interface. As used herein, the term "engage" generally refers to the fact that the mechanical interface of the data reader module or data transmission module, respectively, may mechanically interact with the sensor module mechanical interface (such as by mechanical cooperation). The term "revocable" generally refers to that the interaction may be a separable interaction that is separable by appropriate handling. Generally, the mechanical interfaces of the data reader module and the data transmission module are adapted to alternatively generate a fixed spatial relationship between the sensor module and the data reader module or the sensor module and the data transmission module. Thus, in a first alternative, the data reader module mechanical interface may engage the sensor module mechanical interface, thereby creating a fixed spatial relationship between the sensor module and the data reader module. Thus, in the first alternative, the sensor module and the data reader module are connected. In a second alternative, the data transfer module mechanical interface may engage the sensor module mechanical interface, thereby creating a fixed spatial relationship between the sensor module and the data transfer module. Thus, in this second alternative, the sensor module may be connected to a data transmission module. In the first alternative, the data transmission module may be disconnected from the sensor module, and in the second alternative, the data reader module may be disconnected from the sensor module.

As used herein, the term "fixed spatial relationship" may generally refer to the fact that in a connected state the connecting components (such as the sensor module and the data reader module or the sensor module and the data transmission module) form a connecting unit comprising two components in a predetermined orientation and/or distance. Preferably, the sensor module mechanical interface and the data reader module mechanical interface or the data transmission module mechanical interface may be adapted to form a form-fit or press-fit (force-fit) connection.

The data reader module and/or the data transmission module and optionally one or more other modules (such as an optional alarm module as explained in further detail below) may, in addition to being held in a fixed spatial relationship by the mechanical interface, be further attached to the body of the user by one or more attachment elements. Thus, one or more of these modules may additionally be attached to the user's body by adhesive tape and/or hook and loop fasteners. Thus, by using one or more additional attachment elements, the mechanical stability in the coupled state may be additionally increased.

By using the data reader module and the data transmission module as separate components, the functionality of the kit can be expanded compared to a single sensor module, wherein the volume and resources acquired within the sensor module can still be kept to a minimum. Alternatively, the data reader module and the data transmission module may be coupled to the sensor module. Thus, the configuration of the kit and the coupling of the components of the kit may be adapted to the actual needs of the measurement situation. Thus, in a first state (such as in a state during daily use) the sensor module may be disconnected from the data reader module and from the data transmission module, thereby providing maximum comfort to the user as the weight and volume of the sensor module may be kept at a low level. Thus, the sensor module may have a height of less than 7cm³More preferably below 5cm³Less than 2.5cm³Or even below 2cm³Or less than 1.5cm³The volume of (a). In particular, the sensor module and more preferably the control device of the sensor module may be embodied such that no bulky components, such as bulky wireless far-field communication components and/or bulky data memories, are present. Further, the sensor module may be embodied without any wire-bound data interface, such as without any mechanical plug. Thus, the sensor module may be embodied as an inexpensive, small low-level component that may be simply adapted to acquire measurement data and transmit the measurement data via wireless near-field communication. In addition, however, the sensor module may comprise other components, such as a data storage device (memory), preferably at a low level. Further, the sensor module may include at least one energy storage device,as will be outlined in further detail below.

However, while the sensor module may remain at a low resource level, and thus low level with respect to weight and volume, the kit may provide full functionality of modern analyte systems, such as by providing the ability for far-field data transmission to data processing equipment (such as one or more computers for evaluating measurement data). Further, the data reader module may be used for data storage and/or data transfer in the form of modern memory sticks (such as USB memory sticks).

The kit may further comprise additional components. Thus, as an example, the kit may further comprise at least one alarm module adapted to receive data transmitted by the sensor module via wireless near field communication. The data transmitted by the sensor module may include one or both of measurement data or alarm instructions. The alarm comprises at least one alarm signal that may be adapted to be generated in response to data transmitted by the sensor module.

Thus, as an example, the alarm module may comprise at least one wireless near field communication device, preferably an active near field communication device, communicable with the near field communication device of the control device of the sensor element. As an example, the wireless near field communication device may comprise at least one antenna.

As outlined above, the data transmitted by the sensor module may include alarm instructions. Thus, the alarm module may simply be a passive alarm module adapted to generate an alarm signal in response to an alarm instruction received by the sensor module. Thus, the sensor module may be adapted to determine whether at least one alarm condition is met, such as in the event that one or more thresholds for analyte concentration are exceeded, and if so, may transmit an alarm instruction to the alarm module. The alert module may generate an alert signal in response to the alert instructions.

Additionally or alternatively, the alarm module may provide its own intelligence, at least to some extent, such as by providing one or more processors or other types of data processing devices. Thus, as outlined above, the data transmitted by the sensor module may comprise measurement data. The alarm module may be adapted to evaluate the measurement data and determine whether at least one alarm condition is fulfilled and to provide at least one alarm signal in case the at least one alarm condition is fulfilled. Thus, the alarm module may comprise at least one data processing device, such as at least one processor and/or microcontroller, adapted to execute at least one evaluation algorithm, wherein the evaluation algorithm is configured to evaluate the measurement data received by the sensor module and determine whether an alarm condition is fulfilled. Thus, as an example, the at least one alarm condition may comprise at least one comparison to one or more threshold levels, wherein as an example the alarm condition may be met if a particular threshold level is reached and/or exceeded. Thus, as one example, an alarm condition may be met in the event that a maximum tolerable blood glucose level is exceeded. The alarm module may be flexible with respect to evaluating measurement data. Thus, the alarm module may be a programmable alarm module. As one example, a user may select and/or adjust one or more thresholds to be used in an alarm condition, such as one or more thresholds for analyte concentration. For this purpose, such as for the purpose of programming the alarm module, the alarm module may comprise one or more wireless and/or wired combination interfaces, such as one or more interfaces adapted to be connected to a personal computer, a smartphone or another type of controller. Programming of the alarm module may be possible via one or more of these interfaces.

As will be outlined in further detail below, the at least one alert signal may be generated by at least one alert device. The at least one alarm signal may preferably be selected from the group consisting of an acoustic alarm signal, an optical alarm signal and a vibratory alarm signal. However, other types of alarm signals may be generated, such as an alarm signal transmitted to at least one external device (such as to at least one medical computer) via a wireless or wired combination data transmission.

The alarm module includes at least one mechanical interface adapted to reversibly couple the sensor module mechanical interface to the data reader module and the data transmission module as an alternative. The mechanical interface of the alarm module may also be referred to as an alarm module mechanical interface. For potential embodiments of the alarm module mechanical interface, reference may be made to embodiments of the data reader module mechanical interface and/or the data transmission module mechanical interface as outlined above. Thus, as a third alternative, the alarm module may be coupled to the sensor module, wherein preferably in the third alternative the data reader module and the data transmission module are separate from the sensor module. The alarm module mechanical interface may reversibly engage the sensor module mechanical interface, thereby creating a fixed spatial relationship between the sensor module and the alarm module. Additionally, as outlined above, the alarm module may be attached to the user's body by one or more attachment elements, such as one or more of adhesive tape or hook and loop fasteners.

As outlined above, the alarm module may preferably comprise at least one data evaluation device, also referred to as data processing element. Preferably, the at least one data processing element may have software code stored therein with program means for subjecting the measurement data to at least one alarm condition. Thus, by using a program means, the above mentioned threshold comparison can be performed. Additionally or alternatively, as mentioned above, the alarm module may simply be a passive alarm module adapted to receive one or more alarm instructions from the sensor module and to provide an alarm signal in response to the at least one alarm instruction.

As outlined above, the alarm signal may preferably be selected from the group consisting of an acoustic alarm signal, an optical alarm signal and a vibratory alarm signal. However, additionally or alternatively, other types of alert signals may be generated, such as one or more electronic alert signals (e.g., alert signals transmitted to an external device, such as an external computer and/or smartphone, via a wired combination and/or wireless data transmission, such as a radio transmission). Thus, in general, the alarm signal may be an alarm signal recognizable by a human user (such as a health care worker or a user of the kit) and/or an electronic alarm signal recognizable such as by a machine.

In addition or alternatively to the at least one alarm module, the kit may further comprise at least one portable data management device. The portable data management device may be adapted to receive measurement data directly or indirectly and to display the measurement data at least in part. As used herein, the term at least partially displaying generally refers to the fact that all of the measurement data, a portion thereof, or one or more of the data or information derived from the measurement data is displayed using at least one display device, such as a matrix display. As an example, a measurement curve derived from the measurement data may be displayed on a screen, such as an LCD screen or any other type of display device.

The portable data management device may further be adapted to execute at least one data evaluation algorithm. Thus, the portable data management device may further be adapted to apply at least one data evaluation algorithm on the measurement data or a part thereof, such as to derive at least one evaluation result. As one example, analyte concentration, mean, health, or other types of assessment results may be derived by using an assessment algorithm.

Thus, in general, the data management device may simply be a display device adapted to display only data, while the sensor module and/or data transmission module may provide data evaluation capabilities. Alternatively, the data management device may provide its own intelligence, such as by providing one or more data processing devices adapted to apply the at least one data evaluation algorithm to the measurement data.

As used herein, the term "portable" generally refers to the fact that the data management device may be carried by a user, such as by hand. Thus, the data management device may be a handheld data management device. As an example, the data management device may have a weight of less than 1kg,preferably less than 500g and more preferably less than 300 g. Further, the portable data management device may have a size preferably smaller than 1000cm³More preferably less than 120cm³Or even less than 60cm³The volume of (a).

In general, as used herein, the term "data management device" refers to a device adapted to process measurement data, such as by storing the measurement data and/or subjecting the measurement data to at least one data evaluation algorithm. Thus, as an example, the data management device may have at least one algorithm for displaying the measurement data, such as by displaying the measurement data on a display device, thereby displaying one or more measurement curves. Additionally or alternatively, an averaging algorithm may be applied to the measurement data and/or one or more algorithms adapted to give medical advice to the user. Further, the portable data management device may include one or more databases, such as for storing and/or comparing measurement data.

The portable data management device may be adapted to receive measurement data directly or indirectly. As used herein, the term "directly receiving measurement data" refers to the option of the portable data management device receiving measurement data directly from the sensor module, such as by wireless near field communication. The term "indirectly receiving measurement data" generally refers to an option where at least one intermediate device may be used to fully or partially transfer measurement data to the portable data measurement device. Thus, the at least one data transmission module may be used to transmit the measurement data in whole or in part to the portable data management device via wireless far-field communication. These options will be outlined in more detail below.

In addition to displaying the measurement data and optionally applying at least one evaluation algorithm to the measurement data, the data management device may be further adapted to perform one or more additional actions. Thus, as an example, the data management device may be adapted to initiate one or more other actions in response to the measurement data, such as automatically turning off a drug pump (in particular an insulin pump). Thus, as one example, the data evaluation algorithm may be adapted to determine whether one or more conditions are satisfied based on the measurement data, and may initiate one or more actions (such as turning off the drug pump) in response to the determination.

Further, the data management device may be adapted to send data and/or instructions to one or more other devices. Thus, as an example, the data management device may be adapted to communicate with a sensor module. As an example, the data management device may be adapted to send data to the sensor module, preferably via near field communication. As an example, the data management device may be adapted to transmit calibration data to the sensor module. Additionally or alternatively, the data management device may be adapted to communicate specific alarm conditions and/or alarm adjustments that are individually adjustable by a user.

The portable data management device may include at least one device selected from the group consisting of: a portable computer; a smart phone; a watch; a drug pump (such as an insulin pump) or a portion thereof (such as a drug pump controller); a handheld device for determining a concentration of an analyte in a bodily fluid. Where the portable data management device comprises a handheld device for determining the concentration of an analyte in a bodily fluid, the handheld device may generally comprise any meter for determining the concentration of an analyte. Thus, as an example, the handheld device may be adapted to use at least one test element (preferably a test strip or test strip) having at least one test field, wherein a sample of the body fluid may be applied to the test field. Thus, as opposed to the implantable sensor element of the sensor module, the handheld device may be a point meter adapted to perform an in vitro analysis of a body fluid. Thus, as an example, the handheld device may be a handheld glucose monitoring device using one or more test strips or one or more test strips, wherein a sample of a bodily fluid (such as droplets of blood and/or interstitial fluid) may be applied to the test strips or test strips in order to determine a concentration of an analyte in the bodily fluid (such as a blood glucose concentration). Thus, the handheld device may typically include a commercially available blood glucose meter. Additionally or alternatively, other types of handheld devices for determining analyte concentrations may be used.

The data management device may further include one or more user interfaces that allow a user to insert commands. Thus, the data management device may comprise one or more keys for inserting data and/or commands. The data management device may additionally or alternatively comprise at least one data processing element adapted to apply at least one data processing algorithm to the measurement data. Thus, the data processing element may be adapted to apply at least one averaging algorithm and/or at least one evaluation algorithm to the measurement data, wherein one or more types of information may be derived from the measurement data, such as information on measurement data of analyte concentrations above certain levels, as an example. Further, additionally or alternatively, the data management device may comprise one or more databases for storing measurement data.

The measurement device may be adapted to receive measurement data from the data transmission module via wireless far-field communication. Thus, as one example, the data management device may include one or more far-field communication components, such as one or more radios. Additionally or alternatively, the data management device may be adapted to receive measurement data from the data transmission module via other communication means.

The data management device may further be adapted to receive measurement data directly from the sensor module via wireless near field communication. Thus, the data management device may comprise one or more wireless near field communication devices. Thus, as one example, many handheld devices (such as modern smart phones) include near field communication devices, such as for reading RFID tags. Thus, as one example, the data management device may include one or more RFID readers to receive measurement data from the sensor modules via RFID communication.

The data management device may further comprise at least one display element adapted to display the plurality of measurement data. Thus, the display element may comprise an active or passive display, such as a matrix display. Thus, the display element may be adapted to display a measurement profile comprising a plurality of measurement data. Thus, the measuring device may be adapted to display the temporal development of the measurement data.

Other preferred embodiments relate to a control device. Thus, as outlined above, the control device may preferably comprise at least one energy storage means. The control device may therefore comprise at least one battery and/or at least one energy store. Other types of energy storage devices may be used. The energy storage device may be a rechargeable or non-rechargeable energy storage device.

The control device may further comprise at least one data storage means, such as at least one data memory. Thus, the control device may comprise one or more non-volatile or volatile data stores. However, as outlined above, the data storage of the control device may preferably be kept at a low level, such as for intermediate storage of measurement data.

As outlined above, the wireless near field communication device of the control device may preferably comprise at least one antenna. Thus, the near field communication device of the control device may comprise at least one inductance or inductivity, such as at least one coil, for inductive coupling of signals. As outlined above, the wireless near field communication may comprise an active near field communication or a passive near field communication from the perspective of the near field communication device of the control device of the sensor module. Thus, as an example, the near field communication may be an RFID communication, wherein the wireless near field communication device of the control device of the sensor module may be an active device or a passive device.

Where the wireless near field communication device comprises one or more inductances or inductivities, such as one or more coils, these elements may also be used to provide energy. Thus, as one example, energy (such as energy usable by the control device) may be transferred through inductive coupling.

As outlined above, the wireless far-field communication device of the data transmission module may be adapted to perform radio transmission. Thus, as an example, the wireless far-field communication device of the data transmission module may comprise at least one radio transmitter.

The data reader module may comprise one or more interfaces adapted to communicate the measurement data at least partially to an external device. Thus, as one example, the interface may comprise a wired interface, such as an electrical plug for data transfer. As one example, the wired interface may include a USB interface. However, other types of wired interfaces may additionally or alternatively be used.

The interface may preferably be selected from the group consisting of a USB interface, an infrared interface and a bluetooth interface. However, other types of interfaces may additionally or alternatively be used.

By providing the at least one interface, the data reader module may be used as a data wand. The data reader module may preferably have less than 20cm³Preferably less than 15cm³More preferably less than 10cm³Or even less than 7cm³The volume of (a). Thus, the data reader module may be used as a data transfer stick, allowing intermediate storage of measurement data. The measurement data may be evaluated at a later point in time, such as by connecting the data reader module to at least one computer, such as by using at least one wired-bonded interface and/or wireless interface of the data reader module. Thus, similar to the way a USB stick is used, the data reader module may comprise a USB plug that can be plugged into a port of a computer in order to transfer measurement data to the computer for evaluation purposes and/or database purposes. The data reader module may further include one or more data evaluation algorithms stored thereon that may be communicated to the computer to allow the computer to evaluate the measurement data. As one example, the data reader module may include one or more self-extracting software programs for evaluating measurement data, such as for evaluating continuous glucose monitoring data. The latter generally provides the advantage of not requiring pre-installed software on the computer, so that a user can evaluate or examine the test on any computerVolume data.

Other preferred embodiments relate to a control device. Thus, in general, the control device may comprise a closed housing. As used herein, the term "hermetic" refers to the fact that the housing may include a tight enclosure that is resistant to moisture and/or dirt. The hermetic housing may preferably be a single housing that does not break down into separate housing parts without destroying the housing, i.e. it may not be repeatably separable into housing parts. As one example, the hermetic enclosure may be made of a hermetic plastic material. As one example, a thermoplastic and/or elastomeric material may be used. The hermetic shell may preferably be made of a single piece of material, such as by using a molding process.

The sensor module mechanical interface may be part of the at least one housing and/or may be attached to the at least one housing of the sensor module. Thus, the sensor module mechanical interface may comprise at least one protruding portion formed on the outside of the housing. The protruding portion may comprise a protruding edge, such as a circumferential protruding edge. The protruding portion may provide a simple, quick and reliable mechanical attachment. Numerous other geometric embodiments of the mechanical interface are still possible.

The housing may comprise one or more openings through which an insertion tool for inserting the sensor element into the body tissue can pass through the housing, i.e. can be guided through the housing. Thus, the housing may comprise one or more through holes. As an example, at least one opening may be provided, wherein the opening may in particular be selected from the group consisting of: a through hole passing through the housing along the axis of symmetry; an offset through hole passing through the housing outside the axis of symmetry; an oblique through hole through the housing along a penetration axis, the penetration axis forming an angle α with the symmetry axis of the housing, wherein 0 ° < α < 90 °, preferably 20 ° < α < 70 °, more preferably α = 45 °. As one example, the at least one opening may be a central opening within the housing of the sensor module. The opening may be a through hole penetrating the housing along the axis of symmetry. Additionally, or alternatively, other embodiments are possible.

The kit may further comprise at least one insertion device comprising at least one skin penetrating element adapted to perforate the skin of the user and to guide the sensor element into the body tissue of the user. Thus, the skin penetrating element may comprise at least one cannula. Thus, the cannula may be a needle having a central lumen for accommodating the sensor element during insertion. Preferably, the cannula is a slotted cannula. The insertion device may further comprise at least one drive mechanism for driving a skin penetrating element, such as at least one cannula, into the body tissue. As an example, the drive mechanism may comprise at least one actuator adapted to forcefully move the skin penetrating element through the skin into the body tissue. Thus, as an example, the drive mechanism may comprise at least one spring-based drive mechanism adapted to transform mechanical energy stored in one or more springs into a movement of the skin penetrating element. Drive mechanisms in this way are generally known in the art, such as from US6,360,888B 1. Thus, reference may be made to this document for specific details of embodiments of the drive mechanism. However, other types of drive mechanisms may additionally or alternatively be used.

The insertion device may preferably comprise at least one mechanical interface adapted to engage the sensor module mechanical interface during insertion of the sensor element. Thus, the insertion device may comprise at least one insertion device mechanical interface. The insertion device mechanical interface may be generally embodied in a manner similar to the data reader module mechanical interface and/or the data transmission module mechanical interface. Thus, the insertion device mechanical interface may be adapted to reversibly engage the sensor module mechanical interface, thereby generating a fixed spatial relationship between the sensor module and the insertion device during insertion of the sensor element into the body tissue.

Other preferred embodiments may relate to the connection between the sensor element and the control device. Thus, as outlined above, the sensor element and the control device may be connected by one of a permanent connection and a releasable connection. More preferably, a permanent connection is used.

As outlined above, the sensor element may preferably be a flexible sensor element comprising a flexible substrate and at least two electrodes applied to the flexible substrate. The at least two electrodes may preferably include at least one working electrode having a conductive pad and at least one sensor material applied to the conductive pad. The sensor material may be adapted to perform at least one detection reaction in the presence of an analyte to be detected. The detection reaction may be adapted to change at least one measurable electrical property, such as an electrical property and/or an optical property, of the sensor material. The at least two electrodes may further include at least one of a reference electrode and a counter electrode. The at least one reference electrode and the at least one counter electrode may be embodied as separate electrodes and/or may be embodied as a combined reference-counter electrode.

The control device may have rotational symmetry about an axis of symmetry perpendicular to a surface of the sensor module that lies on a surface of the body of the user when the sensor module is in use. Thus, as one example, the control device may be encased by a housing (such as a plastic housing), as outlined above. The housing may have rotational symmetry about an axis of symmetry perpendicular to the sensor module surface. This rotational symmetry may provide the specific advantage of options with respect to the positioning of the housing and with respect to equal access from all sides. However, in general, any other type of geometric design is feasible.

The sensor module may comprise at least one self-adhesive pad adapted to bond the sensor module to a skin surface of a user. Thus, as one example, the self-adhesive backing may include plaster and/or self-adhesive tape. The self-adhesive pad may be covered with one or more liners prior to use of the sensor module, which may be separated from the self-adhesive pad during application of the sensor module to the skin surface of the user. The control device (preferably the housing of the control device) may be positioned on top of the self-adhesive pad. Thus, the self-adhesive pad may be positioned in between the control device and the skin of the user. The sensor element may penetrate the self-adhesive pad.

Other preferred embodiments relate to the mechanical interface of the sensor module, the data reader module and the data transmission module, and optionally to the mechanical interface of the alarm module. Thus, the sensor module mechanical interface and the data reader module mechanical interface or the data transmission module mechanical interface, and optionally the alarm module mechanical interface, may be adapted to connect in one of a form-fit connection and a press-fit connection. Thus, as outlined above, in a first alternative of possible configurations of the kit, the data reader module mechanical interface may be coupled to the sensor module mechanical interface. In a second alternative configuration, the data transmission module mechanical interface may be coupled to the sensor module mechanical interface. In a third alternative configuration, the alarm module mechanical interface may be coupled to the sensor module mechanical interface. These couplings may preferably be performed by one of a form-fit connection and a press-fit connection.

It should be noted, however, that data transfer between the sensor module and one or more or even all of the data reader module, the data transmission module or, alternatively, the alarm module, must occur in a coupled state. Thus, as one example, one or more of the data reader module, data transmission module or alarm module may simply be held in close proximity to the sensor module so as to allow for the transfer of data and/or instructions, preferably by near field communication.

The mechanical interface of the sensor module and the mechanical interface of the data reader module or the mechanical interface of the data transmission module may preferably be adapted to be connected by means of a dovetail rail. Thus, as outlined above, preferably the housing of the sensor module may provide an edge, such as a circumferential protruding edge. The data reader module mechanical interface and/or the data transmission module mechanical interface may provide appropriate guidance for the edge, thereby creating a dovetail rail connection. Rather, the housing of the sensor module may provide at least one groove, such as a circumferential groove. Accordingly, the data reader module mechanical interface, the data transmission module mechanical interface, or alternatively the alert module mechanical interface may provide at least one rail and/or a protruding portion that may engage the groove. Thus, as an example, the data reader module mechanical interface, the data transmission module mechanical interface or alternatively the alarm module mechanical interface may provide at least one slot into which the housing of the sensor module may be fully or partially inserted, such as by means of guide rails. In general, one or more of the sensor module mechanical interface and the mechanical interface of the data reader module, the data transmission module, and optionally the alarm module, may be adapted to form a key-keyhole connection.

At least one of the mechanical interfaces of the data reader module and the data transmission module may comprise an opening, preferably a slot, wherein the sensor module may be fully or partially inserted into the opening.

Each of the mechanical interface of the data reader module and the mechanical interface of the data transmission module may accordingly comprise a slot inside a housing, such as a housing of the data reader module or a housing of the data transmission module, into which the sensor module may be at least partially inserted. The slot may include a guide rail for guiding the sensor module into the slot. Preferably, the housing of the sensor module can be guided into the groove when the sensor module is applied to the skin surface of the user.

The mechanical interfaces of the data reader module and the data transmission module and optionally the alarm module may be identical. Thus, as an example, the data reader module and the data transmission module and optionally the alarm module may comprise identical housings, with identical mechanical interfaces. To avoid confusion of the modules, the housings of the data reader module and the data transmission module and optionally the alarm module may be of different colours, while the mechanical dimensions are the same. Thus, as one example, the data reader module may have a yellow housing, the data transmission module may have a grey housing, and the alarm module may have a red or orange housing, in order to avoid confusion and/or to promote more intuitive use of the module. Other embodiments are possible.

The sensor module may preferably be a disposable sensor module. Thus, as an example, the sensor module may be embodied such that the sensor module may be arranged as one entity. As outlined above, preferably the sensor module comprises a housing, which preferably cannot be opened in a damage-free manner. Preferably, therefore, the housing of the sensor module is a single piece containing all the components of the control device, including the data collection device and the wireless near field communication device as inexpensive, single use components. A kit according to the present invention may include a plurality of replaceable sensor modules.

Rather, the data reader module and data transmission module and optional alarm module may be embodied as reusable units. Thus, preferably, each of the data reader module, the data transmission module and the optional alarm module may comprise a rechargeable and/or replaceable energy storage device, such as a rechargeable and/or replaceable battery and/or rechargeable energy reservoir. In the case where a rechargeable battery is provided, it is preferred that each of the data reader module, the data transmission module and optionally the alarm module includes a housing that can be opened in a non-damaging manner in order to replace the battery. Where a rechargeable energy storage device is provided, the data reader module, data transmission module, and optional alarm module may include a recharging device, which may be embodied as a wired-coupled recharging device (such as a plug) and/or a wireless charging device (such as an inductive recharging device).

In another aspect of the present invention, a method for determining a concentration of at least one analyte in a bodily fluid of a user is disclosed. The method comprises the use of a kit according to the invention, such as a kit according to one or more of the embodiments disclosed above or as disclosed in further detail below. The method further comprises at least one of the following steps: the method comprises reversibly coupling a data reader module to the sensor module and transferring measurement data from the sensor module to the data reader module via wireless near field communication. After data transfer, the data reader module may be decoupled from the sensor module. The method further comprises at least one step of reversibly coupling the data transmission module to the sensor module and transferring the measurement data from the sensor module to the data transmission module via wireless near field communication. The method may further include decoupling the data transmission module from the sensor module. The coupling of the data reader module to the sensor module occurs before or after the coupling of the data transmission module to the sensor module. Thus, as one example, a user may couple a data reader module to a sensor module on one day and a data transmission module to a sensor module on another day. In general, the coupling of the data reader module or the data transmission module or the coupling of the optional alarm module may occur. Further, each of the coupling of the data reader module to the sensor module and/or the coupling of the data transmission module to the sensor module may occur only once or repeatedly. Once data is read out of the sensor module by one or more of the data reader module, the data transmission module or the optional alarm module, the data may also remain fully or partially stored in the sensor module or may be fully or partially erased from the sensor module after reading.

The method may further comprise at least one step of communicating the measurement data from the data transmission module to at least one external device via wireless far-field communication.

The external device may preferably be selected from the group consisting of: a computer (medical computer such as a physician or medical staff); a computer network; a computer of a medical director; a medical network; a pharmaceutical device (such as an insulin pump).

Optionally, where the kit includes an alarm module as outlined above, the method may further comprise at least one of the steps of reversibly coupling the alarm module to the sensor module and transmitting data from the sensor module to the alarm module, wherein the data transmitted by the sensor module comprises one or both of measurement data or alarm instructions. The method may further comprise at least one step of generating at least one alarm signal in response to the data transmitted by the sensor module. As further outlined above, in case the data transmitted by the sensor module comprises measurement data, the method may comprise at least one step of evaluating the measurement data and determining whether at least one alarm condition is fulfilled, and providing at least one alarm signal in case the at least one alarm condition is fulfilled, by the alarm module. For further details, reference may be made to the disclosure of the alarm module as given above.

The kits and methods according to the present invention provide a number of advantages over known devices for determining analyte concentrations, such as continuous monitoring glucose sensors. Thus, the sensor module itself can be kept at a very low level, thereby maintaining a small volume and weight. Thus, in most simple embodiments, the sensor module may comprise a plastic housing containing the electronic components of the control device. Further, simple plastics may be used for attaching the sensor module to the skin. Thus, first of all, the sensor module may be embodied as a disposable sensor element, such as a disposable patch. Furthermore, the full functionality of modern analytical devices can be provided, even for professional use. Thus, by outsourcing the functionality in the data reader module and the data transmission module and optionally the alarm module, data evaluation, data monitoring and alarm functionality and user interaction may be provided. Thus, the sensor module itself may serve the sole purpose of data collection (such as during the period of use of the sensor element), while the data collection device and the data transmission device may allow for traceable data assessment (such as by a medical professional). Also, the alert function may be provided by coupling an optional alert module to the sensor module, such as during low activity hours of the user (e.g., during the night or rest period).

The wireless near field communication device of the control device requires only a minimum of energy. Thus, in general, reading of measurement data can be performed even without a battery, in case a passive device is provided and/or in case the battery is discharged. Thus, the energy supply of the sensor module can be kept at a minimum level. Furthermore, by wireless near field transmission of measurement data to and from the data transmission module to the external device or directly from the sensor module to the external device via wireless near field communication, the full functionality of the data management device and/or the external computer may be used. The data transmission module (which may also be referred to as a communication module) may include rechargeable and/or replaceable energy storage devices, such as batteries and/or accumulators, and may be reused.

Further, the data transmission module may communicate the measurement data to a remote device, thereby allowing data evaluation and/or identification of critical medical states, such as low glucose levels and/or high glucose levels. Further, as one example, the data transmission module may be used during a particular activity (such as during an exercise or workout) to allow a training staff member to supervise the user, such as by communicating with a remote computer while the data transmission module is coupled to the sensor module. Thus, as one example, online monitoring of long distance runners may be performed. Additionally or alternatively, online monitoring of elderly or hospital patients or care facilities may be performed.

Moreover, the kit provides a high flexibility with regard to an optimal configuration of the system. Thus, by coupling the appropriate components of the kit to the sensor module, the configuration of the kit can be adapted to the actual needs of the situation. Thus, the sensor module may be used as a stand-alone device for collecting measurement data without any other device coupled to the sensor module. Alternatively, one of the data reading module, the data transmission module and the alarm module may be coupled to the sensor module as the actual situation requires. Accordingly, a data reader module may be coupled to a sensor module for data collection, data storage, or data evaluation purposes. Alternatively, the data transmission module may be coupled to the sensor module for data transmission to a remote computer or remote device. Alternatively, an alarm module may be coupled to the sensor module in situations where monitoring is required (such as in intensive care situations and/or during the night). Thus, there is a high flexibility with respect to the actual configuration of the system. Further, as outlined above, direct near field communication with one or more devices (such as a data management device) such as a smartphone may be performed. Thus, as one example, a read of demand initiated by the data management device may be performed. Further, near field communication with the drug pump may be performed.

Summarizing the findings of the present invention, the following examples are preferred. Also, other embodiments are possible.

Example 1: a kit for determining the concentration of at least one analyte in a bodily fluid of a user, the kit comprising:

a) a sensor module, comprising:

i. at least one sensor element adapted to determine a concentration of an analyte, wherein the sensor element is at least partially implantable in a body tissue of a user;

at least one control device connected to the sensor elements, wherein the control device comprises at least one data collection device adapted to collect measurement data acquired by using the sensor elements, wherein the control device further comprises at least one wireless near field communication device adapted to transmit the measurement data,

wherein the sensor module comprises a sensor module mechanical interface;

b) at least one data reader module adapted to receive measurement data transmitted by the sensor module via wireless near field communication, wherein the data reader module comprises at least one data storage device and is adapted to store the measurement data;

c) at least one data transmission module adapted to receive measurement data transmitted by the sensor module via wireless near-field communication, wherein the data transmission module comprises at least one wireless far-field communication device, wherein the wireless far-field communication device is adapted to transmit at least a portion of the measurement data to an external device via wireless far-field communication;

wherein each of the data reader module and the data transmission module comprises a mechanical interface adapted to reversibly engage the sensor module mechanical interface, thereby alternatively generating a fixed spatial relationship between the sensor module and the data reader module or the sensor module and the data transmission module.

Example 2: the kit according to the previous embodiment, wherein the kit further comprises:

d) at least one alarm module adapted to receive data transmitted by the sensor module via wireless near field communication, wherein the data transmitted by the sensor module contains one or both of measurement data or alarm instructions, wherein the alarm module is adapted to generate at least one alarm signal in response to the data transmitted by the sensor module, wherein the alarm module comprises a mechanical interface adapted to reversibly engage a sensor module mechanical interface that is an alternative to the data reader module and the data transmission module, thereby generating a fixed spatial relationship between the sensor module and the alarm module.

Embodiment 3 the kit according to the preceding embodiment, wherein the data transmitted by the sensor module comprises measurement data, wherein the alarm module is adapted to evaluate the measurement data and determine whether at least one alarm condition is fulfilled and to provide an alarm signal in case at least one alarm condition is fulfilled.

Example 4: the kit according to the preceding embodiment, wherein the alarm module comprises at least one data processing element having software code stored therein with program means for subjecting the measurement data to at least one alarm condition.

Example 5: the kit according to any one of the two preceding embodiments, wherein the alarm signal is selected from the group consisting of an acoustic alarm signal, a light alarm signal and a vibration alarm signal.

Example 6: the kit according to any one of the preceding claims, wherein the kit further comprises:

e) a portable data management device, wherein the portable data management device is adapted to receive measurement data directly or indirectly and to display the measurement data at least in part.

Example 7: the kit according to the preceding embodiment, wherein the portable data management device is further adapted to execute at least one data evaluation algorithm.

Example 8: the kit according to any one of the two preceding embodiments, wherein the data management device is adapted to automatically switch off a drug pump, in particular an insulin pump, in response to the measurement data.

Embodiment 9, the kit of any one of the three preceding embodiments, wherein the data management device is adapted to transmit data (preferably calibration data) to the sensor module, preferably via near field communication.

Example 10: the kit according to any of the four preceding embodiments, wherein the portable data management device comprises at least one device selected from the group consisting of: a portable computer; a smart phone; a watch; a drug pump; a handheld device for determining a concentration of an analyte in a body fluid, wherein the handheld device is adapted to use at least one test element having at least one test field, wherein a sample of the body fluid is adapted to be applied to the test field.

Example 11: the kit according to any of the five preceding embodiments, wherein the portable data management device comprises at least one user interface allowing a user to insert commands.

Example 12: the kit according to any of the six preceding embodiments, wherein the portable data management device comprises at least one data processing element adapted to apply at least one data processing algorithm to the measurement data.

Example 13: a kit according to any of the seven preceding embodiments, wherein the portable data management device comprises at least one database for storing measurement data.

Example 14: the kit according to any one of the eight preceding embodiments, wherein the portable data management device is adapted to receive measurement data from the data transmission module via wireless far-field communication.

Example 15: the kit according to any of the nine preceding embodiments, wherein the portable data management device is adapted to receive measurement data directly from the sensor module via wireless near field communication.

Example 16: a kit according to any of the ten preceding embodiments, wherein the data management device comprises at least one display element adapted to display the plurality of measurement data.

Example 17: the kit of any one of the preceding embodiments, wherein the control device comprises an energy storage device.

Example 18: a kit according to any of the preceding embodiments, wherein the control device comprises at least one data storage device.

Example 19: the kit according to any one of the preceding embodiments, wherein the wireless near field communication device of the control device comprises at least one coil for inductive coupling.

Example 20: the kit according to any one of the preceding embodiments, wherein the wireless far-field communication device of the data transmission module comprises at least one radio transmitter.

Example 21: the kit according to any of the preceding embodiments, wherein the data reader module comprises at least one interface adapted to at least partially transmit the measurement data to an external device.

Example 22: the kit as in the previous embodiment, wherein the interface comprises a wired interface.

Example 23: the kit as in the previous embodiments, wherein the wired interface comprises a plug.

Example 24: the kit according to any one of the three preceding embodiments, wherein the interface is selected from the group consisting of: USB interface: an infrared interface; a bluetooth interface.

Example 25: the kit according to any one of the preceding embodiments, wherein the control device comprises a closed housing.

Example 26: the kit according to the preceding embodiment, wherein the hermetic enclosure is made of a plastic material.

Example 27: the kit according to any one of the two preceding embodiments, wherein the containment housing is made of a single piece of material.

Example 28: the kit according to any one of the three preceding embodiments, wherein the sensor module mechanical interface comprises at least one protruding portion formed on an outside of the housing.

Example 29: the kit of parts according to the preceding embodiment, wherein the protruding portion comprises at least one protruding edge.

Example 30: the kit according to the preceding embodiment, wherein the raised edge is a circumferential raised edge.

Example 31: the kit according to any of the six preceding embodiments, wherein the housing comprises an opening through which an insertion tool for inserting the sensor element into the body tissue can pass through the housing.

Example 32: the kit according to the previous embodiment, wherein the opening is a central opening.

Example 33: the kit according to any one of the two preceding embodiments, wherein the opening is an opening selected from the group consisting of: a through hole passing through the housing along the axis of symmetry; an offset through hole passing through the housing outside the axis of symmetry; an oblique through hole through the housing along a penetration axis, the penetration axis forming an angle α with the symmetry axis of the housing, wherein 0 ° < α < 90 °, preferably 20 ° < α < 70 °, more preferably α = 45 °.

Example 34: the kit according to any of the preceding embodiments, wherein the kit further comprises:

f) an insertion device comprising at least one skin penetrating element adapted to perforate the skin of a user and to guide the sensor element into the body tissue of the user.

Example 35: the kit according to the previous embodiment, wherein the skin penetrating element comprises at least one catheter.

Example 36: the kit according to any of the two preceding embodiments, wherein the insertion device further comprises at least one driving mechanism for driving the skin penetrating element into the body tissue.

Example 37: the kit according to any one of the three preceding embodiments, wherein the insertion device comprises at least one mechanical interface adapted to engage the sensor module mechanical interface during insertion of the sensor element.

Example 38: the kit according to any one of the preceding embodiments, wherein the sensor element and the control device are connected by one of a permanent connection or a releasable connection.

Example 39: a kit according to any one of the preceding embodiments, wherein the sensor element is a flexible sensor element comprising a flexible substrate and at least two electrodes applied to the flexible substrate.

Example 40: the kit according to the preceding embodiment, wherein the at least two electrodes comprise at least one working electrode having a conductive pad and at least one sensor material applied to the conductive pad, wherein the sensor material is adapted to perform at least one detection reaction in the presence of the analyte to be detected, wherein the detection reaction changes at least one measurable electrical property of the sensor material.

Example 41: the kit according to any one of the two preceding embodiments, wherein the at least two electrodes further comprise at least one of a reference electrode and a counter electrode.

Example 42: a kit according to any one of the preceding embodiments, wherein the control device has rotational symmetry about an axis of symmetry perpendicular to a surface of the sensor module, the surface of the sensor module being located on a surface of a body of a user when the sensor module is in use.

Example 43: the kit according to any of the preceding embodiments, wherein the sensor module comprises at least one self-adhesive patch adapted to adhere the sensor module to a skin surface of a user.

Example 44: the kit according to the preceding embodiment, wherein the control device is positioned on top of the self-adhesive patch.

Example 45: the kit according to any of the two preceding embodiments, wherein the sensor element penetrates a self-adhesive patch.

Example 46: the kit according to any of the preceding embodiments, wherein the sensor module mechanical interface and the mechanical interface of the data reader module or the mechanical interface of the data transmission module are adapted to be connected by at least one of a form-fit connection or a press-fit connection.

Example 47: the kit according to any one of the preceding embodiments, wherein the mechanical interface of the sensor module and the mechanical interface of the data reader module or the mechanical interface of the data transmission module are adapted to be connected by a dovetail rail.

Example 48: the kit according to any one of the preceding embodiments, wherein the sensor module mechanical interface and the mechanical interface of the data reader module or the mechanical interface of the data transmission module are adapted to form a key-keyhole connection.

Example 49: the kit according to any of the preceding embodiments, wherein at least one of the mechanical interface of the data reader module and the mechanical interface of the data transmission module comprises an opening, wherein the sensor module can be fully or partially inserted into the opening.

Example 50: the kit according to any of the preceding embodiments, wherein each of the mechanical interface of the data reader module and the mechanical interface of the data transmission module comprises a slot inside the housing of the data reader module and the data transmission module, respectively, wherein the sensor module can be at least partially inserted into the slot.

Example 51: the kit according to the preceding embodiment, wherein the slot comprises a track for guiding the sensor module into the slot.

Example 52: the kit according to any one of the preceding embodiments, wherein the mechanical interface of the data reader module and the mechanical interface of the data transmission module are identical.

Example 53: the kit of any one of the preceding embodiments, wherein the sensor module is a disposable sensor module.

Example 54: the kit according to the preceding embodiment, wherein the kit comprises a plurality of replaceable sensor modules.

Example 55: the kit according to any one of the preceding embodiments, wherein the data reader module and the data transmission module are reusable units.

Example 56: a method for determining the concentration of at least one analyte in a body fluid of a user, the method comprising the use of a kit according to one of the preceding embodiments, the method further comprising at least one step of reversibly coupling a data reader module to the sensor module and transferring measurement data from the sensor module to the data reader module via wireless near field communication, the method further comprising at least one step of reversibly coupling a data transmission module to the sensor module and transferring measurement data from the sensor module to the data transmission module via wireless near field communication.

Example 57: the method according to the preceding embodiment, the method further comprising at least one step of communicating the measurement data from the data transmission module to at least one external device via wireless far-field communication.

Example 58: the method according to the preceding embodiment, wherein the external device is selected from the group consisting of: a computer; a computer network; a computer of a medical director; a medical network; a pharmaceutical device; a remote control for a drug pump (in particular an insulin pump) and/or a micro pump; a smart phone.

Drawings

Further optional features and embodiments of the invention will be disclosed in more detail in the subsequent description of the preferred embodiments, preferably in conjunction with the dependent claims. Wherein the respective optional features may be implemented in isolation and in any arbitrary feasible combination, as will be appreciated by a person skilled in the art. The scope of the invention is not limited by the preferred embodiments. This embodiment is schematically depicted in the figure. Wherein identical reference numbers in the figures denote identical or functionally comparable elements.

In the figure:

figure 1 shows an overview of a potential embodiment of a kit according to the invention;

FIG. 2 illustrates the interaction between a sensor module and a data reader module of a kit according to the present invention;

3A-3D illustrate potential embodiments of the interaction of a sensor module, a data transmission module, and an external device according to embodiments of the kit of the present invention;

FIG. 4 illustrates the interaction of a sensor module and an alarm module;

FIG. 5 illustrates the interaction of a sensor module and a portable data management device; and

fig. 6A to 6D show different uses of the components of a kit according to the invention, further comprising an insertion device for inserting the sensor element into the body tissue of a user.

Detailed Description

In fig. 1, various components of a kit 110 for determining a concentration of at least one analyte in a bodily fluid of a user are shown. The kit includes a sensor module 112 depicted in a stand-alone fashion in the middle of fig. 1. The sensor module comprises a sensor element 114 adapted to be at least partially implanted in body tissue of a user. The sensor element 114 is connected to a control device 116 which is enclosed by a housing 118. As will be outlined in further detail below, the control device 116 comprises at least one data collection device 120 and at least one wireless near field communication device 122. The sensor module 112 further comprises at least one self-adhesive patch 124 adapted to mount the sensor module 112 to a skin surface of a user.

The sensor module 112 further includes a sensor module mechanical interface 126. In this particular embodiment, the sensor module mechanical interface 126 includes a circumferential raised edge 128, which may be a part of the housing 118 (as depicted in fig. 1) or which may be attached to the housing 118, as one example.

As depicted in fig. 1, the sensor module 112 may have rotational symmetry, and preferably may have less than 2cm³The volume of (a). Further, the housing 118 may have a central opening 130 for insertion of the sensor element 114An insertion tool in the body tissue may pass through the housing 118 through the central opening 130.

The kit 110 further includes a data reader module 132, a data transmission module 134, and optionally an alarm module 136. These

modules

132, 134, 136 may generally have identical or similar geometries and dimensions. Moreover, the

modules

132, 134, 136 may be distinctive in terms of color and/or indicia or markings.

Each of the

modules

132, 134, 136 has a mechanical interface for reversibly coupling the respective module to the sensor module 112, thereby providing a fixed spatial relationship between the sensor module 112 and the

respective module

132, 134, 136. In this particular example, a form-fitting connection may be provided. Thus, the data reader module 132 has a data reader module mechanical interface 138, the data transmission module 134 has a data transmission module mechanical interface 140, and the alarm module 136 has an alarm module mechanical interface 142. In this particular embodiment, each of the

mechanical interfaces

138, 140, 142 includes a slot 144 having a guide rail 146 that may engage the circumferential ledge 128 of the sensor module 112. In the exemplary embodiment shown in FIG. 1, the data reader module 132 is shown in a decoupled state, while the data transmission module 134 and the alarm module 136 are shown in a state in which the sensor module 112 is inserted into the slot 144, thereby providing a fixed spatial relationship between the sensor module 112 and the

respective modules

134, 136.

As will be outlined in more detail below, the data reader module 132 is adapted to receive measurement data transmitted by the sensor module 112 via wireless near field communication. For this purpose, the data reader module 132 may comprise a wireless near field communication device 148. Similarly, each of the data transmission module 134 and optionally the alarm module 136 may include a wireless near field communication device 148.

The data reader module 132 further comprises at least one data storage device 150 and is adapted to store measurement data transmitted by the sensor module 112 via wireless near field communication. The at least one data transmission module 134 comprises at least one wireless far-field communication device 152 (such as at least one radio module), wherein the wireless far-field communication device 152 is adapted to transmit at least a part of the measurement data to an external device via wireless far-field communication. As an example, in FIG. 1, wireless near field communication between sensor module 112 and data transmission module 134 is represented by reference numeral 154, and as an exemplary embodiment, an external device is represented by reference numeral 156. As an exemplary embodiment, wireless far-field communication between the data transmission module 134 and the external device 156 is represented by reference numeral 158.

The alarm module 136 may include at least one data processing element 160 and may be adapted to evaluate the metric data to determine whether at least one alarm condition is satisfied. Further, the alarm module 136 is adapted to provide at least one alarm signal if at least one alarm condition is met. For this purpose, the alarm module 136 may comprise at least one alarm signal generator 162, such as an alarm signal generator 162 selected from the group consisting of an acoustic alarm signal generator, an optical alarm signal generator and a vibratory alarm signal generator. Thus, as one example, in the event that an alarm condition is determined to be satisfied, the alarm module 136 may vibrate and/or give an acoustic alarm signal (such as an alarm sound), and/or may provide a light alarm signal, such as by providing repeated flashing of light and/or by changing the lighting state.

The

modules

132, 134 and 136 may be designed as reusable components and preferably each may have a housing 164. As one example, the housing 164 may provide an option of being opened to replace the battery.

As depicted in the exemplary embodiment of fig. 1, the kit 110 may further include at least one portable data management device 166. As outlined above, the portable data management device 166 may preferably be a handheld device, such as a handheld computer and/or a handheld communication device (preferably a smartphone). The portable data management device 166 may be identical to the external device 156 or may form a separate component from the external device 156. As will be outlined in further detail below, in one option, the portable data management device 166 may communicate directly with the sensor module 112 via wireless near field communication 154 in order to receive measurement data. However, additionally or alternatively, the portable data management device 166 may communicate with the data transmission module 134 via wireless far-field communication 158, as indicated for the external device 156 in fig. 1.

The portable data management device 166 may include at least one user interface 168 that allows a user to insert commands and/or information. As indicated in fig. 1, the user interface 168 may include a touch screen. The portable data management device 166 may further comprise at least one display element 170 for displaying data and/or measurement results and/or additional information.

As outlined above, the portable data management device 166 may comprise at least one data processing element 172 (such as at least one processor) adapted to apply at least one data processing algorithm to the measurement data. The portable data management device 166 may further include at least one data storage device and/or memory, such as at least one database, for storing measurement data.

The portable data management device 166 is adapted to apply at least one data processing algorithm to the measurement data. As outlined above, the data processing algorithm may mean a visualization of the measurement data, such as a graphical display of the measurement curve. Further, one or more additional information items may be generated by evaluating the measurement data (such as by comparing the measurement data to one or more thresholds) in order to generate information about the medical state of the user.

For communication via near field communication, the portable data management device 166 may optionally include at least one wireless near field communication device 148. For wireless far-field communication, the portable data management device 166 may further comprise at least one wireless far-field communication device 152, as indicated in fig. 1.

In the following, specific interactions of the components of the kit 110 are disclosed in exemplary detail. Thus, in fig. 2, one embodiment of the interaction of the data reader module 132 with the sensor module 112 is schematically depicted, allowing for a retrospective reading of measurement data and/or a retrospective evaluation of measurement data.

As indicated above, the sensor module 112 as depicted in fig. 2 may be operated such that the sensor elements 114 are at least partially implanted in the body tissue 174 of the user. In this state or even in a state in which the sensor element 114 is not implanted in the body tissue 174, the sensor module 112 may communicate with the data reader module 132 via the wireless near field communication 154 in order to transmit measurement data. The data reader module 132 may store the measurement data in the data storage device 150. At a later point in time, the data reader module 132 may transfer the measurement data, in whole or in part, to the external device 156 having a corresponding interface 178 via at least one interface 176. As one example, the external device 156 may include a computer such as a personal computer, a smart phone, a controller, or a blood glucose meter. Other options are listed above. The

interfaces

176, 178 may allow data transfer 180, which may be a wired combination data transfer and/or a wireless data transfer. As one example, the interface 176 may include a plug (such as a USB plug) that may be plugged into a corresponding plug of the external device 156. Additionally or alternatively, wireless transfer may occur, such as data transfer 180 via infrared data transfer, bluetooth, or other types of wireless data transfer. In particular, the data reader module 132 may be used in the same manner as a USB data stick. The user (in particular the patient) may regularly collect measurement data by using the data reader module 132 and may communicate the measurement data to a medical professional (such as a doctor) by simply carrying the data reader module 132 to the medical professional's office. Additionally or alternatively, the data reader module 132 may provide sufficient storage capacity for storing measurement data over an extended period of time, such as over one or more weeks.

In fig. 3A-3D, various interactions of sensor module 112 with data transmission module 134 and, optionally, one or more external devices 156 and/or portable data management device 166 are depicted. Thus, in general, FIG. 3A illustrates the schematic interaction of these components in a manner similar to the arrangement illustrated in FIG. 2. Thus, in general, reference may be made to the description of fig. 1 and 2 above with respect to the sensor module 112 and with respect to the data transmission module mechanical interface 148. The measurement data may be communicated from the sensor module 112 to the data transmission module 134 via wireless near field communication 154, such as in a state in which the data transmission module 134 is mechanically coupled to the sensor module 112. Thus, in general, in this or other embodiments of the invention, the

mechanical interfaces

138, 140 and 142 of the

modules

132, 134 and 136 may be adapted such that wireless near field communication 154 between the sensor module 112 and the

respective modules

132, 134 and 136, respectively, is possible when coupling the

respective modules

132, 134 and 136 to the sensor module mechanical interface 126. Thus,

mechanical interfaces

126 and 138, 140 and 142, respectively, may be adapted such that in the coupled state the distance between wireless near-field communication device 122 of sensor module 112 and wireless near-field communication device 148 of

respective modules

132, 134 and 136 is closer than 1 cm.

As outlined in fig. 3A, the data transmission module 134 may transmit at least a portion of the measurement data to one or more external devices 156 via wireless far-field communication 158 using its wireless far-field communication device 152. Thus, online monitoring may be possible as opposed to the traceable data evaluation provided by the data reader module 132. As outlined above, the external device 156 may have a corresponding wireless far-field communication device 182. As an example, the wireless far-

field communication device

152, 182 may be designed as a radio transmitter, a radio receiver and/or a radio transceiver.

As outlined above, the external device 156 may be a fixed external device or a portable external device. Thus, in the case of a portable external device, the portable device may be portable data management device 166, as outlined above. In particular, the external device 156 may include one or more of a smartphone, a tablet PC, an app on a smartphone or tablet PC, a controller and/or data manager, a personal computer, a drug pump (particularly an insulin pump), and/or a spot meter (such as a blood glucose meter) using one or more test elements for determining analyte concentration. Other options are possible. In particular, in this or other embodiments, the external device 156 may provide at least one data evaluation function and/or at least one alarm function.

In fig. 3B, several details of a potential setup for near field communication between the data transmission module 134 and the sensor module 112 are depicted. The wireless near field communication 154 may be unidirectional or bidirectional. Thus, in a unidirectional manner, only the transmission of measurement data from the sensor module 112 to the data transmission module 134 may occur. However, in the bi-directional mode, the data transmission module 134 may transmit commands and/or information to the sensor module 112. Additionally, the data transmission module 134 may transfer energy to the sensor module 112, such as via inductive coupling.

As depicted in fig. 3B, the wireless near-field communication device 122 of the sensor module 112 may include an antenna 184. The data collection device 120 may include one or more signal processing devices 186. Further, there may be one or more potentiostats and/or other electronic measurement components.

Further, the control device 116 of the sensor module 112 may include one or more data storage devices 188, such as one or more volatile and/or non-volatile data storage components.

The sensor module 112 may also include one or more energy storage devices 190. Thus, as one example, one or more batteries and/or accumulators may be implanted in the sensor module 112.

The wireless near field communication device 148 of the data transmission module 134 may include one or more antennas 192. Further, the data transmission module 134 may include one or more energy storage devices 194, such as one or more accumulators and/or one or more batteries. Preferably, the at least one energy storage device 194 is rechargeable and/or replaceable.

The data transfer module 134 may further include at least one data storage device not depicted in fig. 3B. Further, as outlined above, the data transmission module 134 comprises a wireless far-field communication device 152. Among other things, several standards for wireless far-field communication may be used. As an example, a radio standard may be used, such as a bluetooth standard, in particular a bluetooth low energy standard (BTLE), and/or a radio standard, such as GSM. These options are depicted in fig. 3C and 3D. Thus, as an exemplary embodiment, in fig. 3C, a wireless far-field communication 158 with an external device 156 is depicted, wherein in this embodiment the external device 156 may be embodied as a portable data management device 166, in particular a watch 196, more preferably a wristwatch. Wherein preferably bluetooth communication (such as BTLE) is chosen.

In fig. 3D, an embodiment is shown without the sensor module 112 (which may otherwise be present), wherein wireless far-field communication 158 may occur between the data transmission module 134 and an external device 156 (such as a smartphone 198) via a known radio standard for telecommunication purposes (such as one or more of GSM, UMTS, and LTE).

In fig. 4, the interaction of the sensor module 112 and the alarm module 136 is depicted in a similar arrangement as that shown in fig. 2 and 3A. Wherein, in a state in which the alarm module mechanical interface 142 is coupled to the sensor module mechanical interface 126, the sensor module 112 may transmit measurement data to the alarm module 136 via the wireless near field communication 154. As set forth above, the alarm module 136 comprises a data processing element 160 adapted to evaluate the measurement data and determine whether at least one alarm condition is met. Further, the alarm module 136 includes an alarm signal generator 162 to provide at least one alarm signal if at least one alarm condition is met. Thus, optical, vibrational or acoustical signals or any arbitrary combination thereof may be provided.

In fig. 5, another option for communication between sensor module 112 and optional portable data management device 166 is depicted. In this embodiment, the portable data management device 166 may itself comprise at least one wireless near field communication device 148, as was the case with modern smart phones, as outlined above. In this option, the sensor module 112 may transmit data to the portable data management device 166 via near field communication 154, which may occur over short distances, even through the article of clothing 200.

As outlined above, the kit 100 may further comprise at least one insertion device. In fig. 6A-6D, several views of the components of the kit 110 are depicted, representing potential details of insertion. Thus, fig. 6C again shows a potential embodiment of the sensor module 112, which may comprise an opening 130, preferably a central opening 130, preferably a through hole. For details of the sensor module 112, reference may be made to FIG. 1 above.

In the delivery state, the kit may include an insertion device 202, which may include at least one skin penetrating element 204 (such as at least one catheter 206). In fig. 6A and 6D, various embodiments of a conduit 206 of the sensor module 112 having an opening 130 penetrating the housing 118 of the sensor module 112 are depicted.

As depicted in fig. 6B, the insertion device 202 may further comprise at least one drive mechanism 208 for driving the skin-penetrating element 204 into the body tissue 174. As one example, the drive mechanism may include at least one actuator 210 having an actuator mechanical interface 212 adapted to engage the sensor module 112 and/or the skin penetrating element 204. The actuator 210 may be a spring-loaded actuator adapted to move within a guide track 214 of a frame 216 of the insertion device 202. The insertion device 202 may further comprise a trigger 218 which may be pressed against the skin surface of the user in order to trigger the driving action of the actuator 210 and drive the skin penetrating element 204 into the body tissue 174, thereby implanting the sensor element 114 in the body tissue 174. After insertion of the sensor element 114, the actuator 210 may be pulled back out of the body tissue 174, with the sensor element 114 remaining within the body tissue 174. During this reverse action, the skin penetrating element 204 may be withdrawn from the opening 130 with the module 112 still on the skin surface of the user with the self-adhesive patch 124 adhered to the user's skin.

The kit 110 according to the embodiment shown in the figures, together with the sensor module 112, the data reader module 132, the data transmission module 134, the optional module 136 and the optional portable data management device 166 and the optional plug-in device 202 allow for a number of preferred operations. Thus, during daily use or during athletic activities, the sensor module 112 may be worn as a standalone application with maximum comfort to the user. The

modules

132, 134, and 136 may be coupled to the sensor module 112 at periodic or non-periodic intervals, respectively, as appropriate to the individual's needs.

Thus, during the night, the sensor module 112 may be coupled to one of the data reader module 132, the data transmission module 134, or the alarm module 136. Thus, as one example, when coupled to the data transmission module 134, the data transmission module 134 may communicate the measurement data to a data manager, a smart phone with a monitoring application (such as a CGM application), a personal computer, or other external device 156. The external device may be adapted to give an alarm in case an alarm condition is fulfilled, such as a low blood glucose level and/or a high blood glucose level.

Similarly, the alarm module 136 may be worn as a smart patch with all electronics and algorithms on board during the night and/or during athletic activities to give a significant alarm when one or more alarm conditions are met, such as in the case of detection of low and/or high blood glucose levels. Thus, the alarm module may wake up the user during the night, in case an alarm condition is fulfilled, such as by giving a vibration alarm and/or an alarm sound.

The coupling of the data reader module 132 to the sensor module 112 allows for retrospective reading and/or evaluation of data. Data readings may be performed on an occasional basis, as the sensor module 112 may preferably be capable of storing measurement data itself over an extended period of time, such as over hours, days, or even weeks (such as up to seven days or longer). The data reader module 112 may communicate with the sensor module 112 and read out data in short periods of time, on a periodic or aperiodic basis, such as during daytime hours. The data reader module 132 may then or simultaneously be coupled to an external device 156, such as a smartphone with a specific application, such as a CGM application, or the data reader module 132 may be read out via a computer, such as a personal computer in a physician's office. The data reader module 134 may be maintained at a low level without any display and/or user interface. However, as outlined above, the data reader module 132 preferably provides one or more electronic interfaces (such as one or more wireless and/or wired combination interfaces) for data transfer 180 to external devices 156 (such as one or more USB connectors).

The additional option of using the smart sensor module 112 directly in conjunction with the portable data management device 166 allows for direct reading of measurement data via wireless near field communication. Thus, a smartphone with a wireless near field communication device 148 may be used for data transfer through the article of clothing 200 via wireless near field communication 154 of measurement data. The portable data management device 166 (such as a smartphone) may include one or more applications (such as one or more monitoring applications) for evaluating data.

Providing additional options for inserting the device 202 within the kit 110 may accomplish the flexibility of the kit 110. Thus, as the insertion device 202, commercially available insertion devices, which are typically used for insertion of catheters of infusion sets and/or drug pumps (such as insulin pumps), may be used for insertion of the sensor element 114. Thus, the insertion effort can be kept at a very low level and known insertion devices can be used, such as insertion devices familiar to many patients (such as insertion devices for catheters of insulin pumps). Thus, in particular, additional training may be avoided. In particular, the sensor module 112 may be designed as a disposable sensor module, and the kit 110 may include a plurality of replaceable and disposable sensor modules 112.

List of reference numerals

110 kit for determining the concentration of an analyte in a body fluid of a user

112 sensor module

114 sensor element

116 control device

118 outer casing

120 data collection device

122 wireless near field communication device

124 self-adhesive patch

126 sensor module mechanical interface

128 circumferential raised edge

130 opening

132 data reader module

134 data transmission module

136 alarm module

138 data reader module mechanical interface

140 mechanical interface of data transmission module

142 alarm module mechanical interface

144 groove

146 guide rail

148 wireless near field communication device

150 data storage device

152 wireless far-field communication device

154 wireless near field communication

156 external device

158 wireless far field communication

160 data processing element

162 alarm signal generator

164 outer casing

166 portable data management device

168 user interface

170 display

172 data processing element

174 body tissue

176 interface

178 interface

180 data transfer

182 wireless far-field communication device

184 aerial

186 signal processing apparatus

188 data storage device

190 energy storage device

192 antenna

194 energy storage device

196 watch

198 Intelligent telephone

200 clothes

202 insertion device

204 skin penetrating element

206 guide tube

208 driving mechanism

210 actuator

212 actuator mechanical interface

214 guide rail

216 frame

218 flip-flop.

Claims

1. A kit (110) for determining a concentration of at least one analyte in a bodily fluid of a user, the kit (110) comprising:

a) a sensor module (112) comprising:

i. at least one sensor element (114) adapted to determine a concentration of an analyte, wherein the sensor element (114) is at least partially implantable in a body tissue (174) of a user;

at least one control device (116) connected to the sensor element (114), wherein the control device (116) comprises at least one data collection device (120), the at least one data collection device (120) being adapted to collect measurement data acquired by using the sensor element (114), wherein the control device (116) further comprises at least one wireless near field communication device (122) adapted to transmit the measurement data,

wherein the sensor module (112) comprises a sensor module mechanical interface (126);

b) at least one data reader module (132) adapted to receive measurement data transmitted by the sensor module (112) via wireless near field communication, wherein the data reader module (132) comprises at least one data storage device (150) and is adapted to store the measurement data;

c) at least one data transmission module (134) adapted to receive measurement data transmitted by the sensor module (112) via wireless near-field communication, wherein the data transmission module (134) comprises at least one wireless far-field communication device (152), wherein the wireless far-field communication device (152) is adapted to transmit at least a portion of the measurement data to an external device (156) via wireless far-field communication;

wherein each of the data reader module (132) and the data transmission module (134) comprises a mechanical interface (138, 140) adapted to reversibly engage the sensor module mechanical interface (126), thereby alternatively generating a fixed spatial relationship between the sensor module (112) and the data reader module (132) or the sensor module (112) and the data transmission module (134),

wherein the data reader module and the data transmission module are separate components.

2. The kit (110) according to claim 1, wherein the kit (110) further comprises:

d) at least one alarm module (136) adapted to receive data transmitted by the sensor module (112) via wireless near field communication, wherein the data transmitted by the sensor module (112) contains one or both of measurement data or alarm instructions, wherein the alarm module (136) is adapted to generate at least one alarm signal in response to the data transmitted by the sensor module (112), wherein the alarm module (136) comprises a mechanical interface (142), the mechanical interface (142) being adapted to revocable engage the sensor module mechanical interface (126) as an alternative to the data reader module (132) and the data transmission module (134), thereby generating a fixed spatial relationship between the sensor module (112) and the alarm module (136).

3. The kit (110) according to claim 2, wherein the data transmitted by the sensor module (112) comprises measurement data, wherein the alarm module (136) is adapted to evaluate the measurement data and determine whether at least one alarm condition is fulfilled and to provide an alarm signal in case at least one alarm condition is fulfilled.

4. The kit (110) according to claim 1 or 2, wherein the kit (110) further comprises:

e) a portable data management device (166), wherein the portable data management device (166) is adapted to receive measurement data directly or indirectly and to display data at least in part.

5. The kit (110) according to claim 4, wherein the portable data management device (166) is adapted to receive measurement data from the data transmission module (134) via wireless far-field communication.

6. The kit (110) according to claim 4, wherein the portable data management device (166) is adapted to receive measurement data directly from the sensor module (112) via wireless near field communication.

7. The kit (110) according to claim 1 or 2, wherein the wireless far-field communication device (152) of the data transmission module (134) comprises at least one radio transmitter.

8. The kit (110) according to claim 1 or 2, wherein the data reader module (132) comprises at least one interface (176) adapted to communicate the measurement data at least partially to an external device (156).

9. The kit (110) according to claim 1 or 2, wherein the control device (116) comprises a hermetic housing (118), wherein the sensor module mechanical interface (126) comprises at least one protruding portion (128) formed on an outer side of the housing.

10. The kit (110) according to claim 1 or 2, wherein the kit (110) further comprises:

f) an insertion device (202), the insertion device (202) comprising at least one skin penetrating element (204) adapted to perforate the skin of the user and to guide the sensor element (114) into the body tissue (174) of the user.

11. The kit (110) according to claim 1 or 2, wherein the sensor module mechanical interface (126) and the mechanical interface (138) of the data reader module (132) or the mechanical interface (140) of the data transmission module (134) are adapted to be connected by one of a form-fit connection and a press-fit connection.

12. The kit (110) according to claim 1 or 2, wherein the sensor module mechanical interface (126) and the mechanical interface (138) of the data reader module (132) or the mechanical interface (140) of the data transmission module (134) are adapted to be connected by a dovetail rail.

13. The kit (110) according to claim 1 or 2, wherein the mechanical interface (138) of the data reader module (132) and the mechanical interface (140) of the data transmission module (134) each comprise a slot (144) inside the housing of the data reader module (132) and the data transmission module (134), respectively, wherein the sensor module (112) can be inserted at least partially into the slot (144).

14. The kit (110) according to claim 1 or 2, wherein the sensor module (112) is a disposable sensor module (112).

15. The kit (110) according to claim 1 or 2, wherein the data reader module (132) and the data transmission module (134) are reusable units.

16. A method for determining the concentration of at least one analyte in a body fluid of a user, the method comprising using a data reader module (132) and a data transmission module (134) in a kit (110) according to claim 1, the method further comprising at least one of the following two steps: -reversibly coupling the data reader module (132) to the sensor module (112) and-transferring the measurement data from the sensor module (112) to the data reader module (132) via wireless near field communication, the method further comprising at least one of the following two steps: -reversibly coupling the data transmission module (134) to the sensor module (112) and-transferring the measurement data from the sensor module (112) to the data transmission module (134) via wireless near field communication.

17. The method of claim 16, further comprising at least one of: the measurement data is communicated from the data transmission module (134) to at least one external device (156) via wireless far-field communication.